Clindamycin Phosphate 1.2 g / tretinoin 0.25 g
Each 100g gel contains:
Clindamycin Phosphate 1.2 g
tretinoin 0.25 g
molecular formula: C18H34ClN2O8PS
molecular formula: C20H28O2
Mechanism of Action:
Probably due to its antibacterial activity. Topical clindamycin is thought to reduce free fatty acid concentrations on the skin and to suppress the growth of Propionibacterium acnes (Corynebacterium acnes), an anaerobe found in sebaceous glands and follicles. P.acnes produces proteases, hyaluronidases, lipases, and chemotactic factors, all of which can produce inflammatory components or inflammation directly.
By stimulating the transcription process, tretinoin increases epidermal cell mitosis and epidermal cell turnover
Small amounts of clindamycin may be absorbed after topical application to the skin; bioavailability from topical preparations of phosphate has been reported to be about 2%.
Absorption: Systemic absorption: only 1.41% may be increased when applied to large surface areas, or for long periods of time in chronic extensive dermatoses. Duration of action: Although gradual, most patients will show some improvement in skin condition within the first 6 to 7 weeks for the treatment of acne. Elimination: Renal- 4.45% of applied dose.
Acne vulgaris (treatment): Topical clindamycin and tretinoin are indicated for the treatment of acne vulgaris. It may be effective in grades II and III acne, which are characterized by inflammatory lesions such as papules and pustules. (tretinoin alone is effective in the topical treatment of mild acne vulgaris (Grades I to III), the therapeutic effect may be increased when tretinoin used in combination with topical antibiotics).
It is contraindicated in individuals with a history of hypersensitivity to preparations containing tretinoin, clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis have been reported with the use of topical clindamycin.
For external use only: keep away from the eyes, mouth, angles of the nose, and mucous membranes.
Usage in pregnancy: FDA Pregnancy Category C.
It is recommended that topical tretinoin not be used during pregnancy.
Breast-feeding: It is not known whether tretinoin is distributed into breast milk. Risk-benefit should be considered.
Pediatrics: Safety and efficacy have not been established for children up to 12 years of age.
Patients sensitive to acitretin, etretinate, isotretinoin, or other vitamin A derivatives may be sensitive to tretinoin also, since it is a vitamin A derivative.
Abrasive or medicated soaps or cleansers or Acne preparations or preparations containing a peeling agent, such as:Resorcinol, Salicylic acid, Sulfur Alcohol-containing preparations , topical, such as: After-shave lotions,Perfumed toiletries Cosmetics or soaps with a strong drying effect. Medicated cosmetics or “cover-ups”: Concurrent use with topical clindamycin may cause a cumulative irritant or drying effect, especially with the application of peeling, desquamating, or abrasive agents, resulting in excessive irritation of the skin. Retinoids, such as: Isotretinoin, Tretinoin, oral Photosensitizing medications, such as: Fluoroquinolones, Phenothiazines, Sulfonamides, Thiazide diuretics.Concurrent use may increase risk of photosensitivity.
Dryness, scaliness, or peeling of skin. hypersensitivity, gastrointestinal disturbances, irritation, stinging or burning feeling of skin, erythema ; hypopigmentation of treated skin, scaling of skin, unusually dry or oily skin.
Pseudomembranous colitis, Hyperpigmentation of treated skin.
Dosage and Administration:
Usual adult dose: Topical, to the skin, a thin film applied two times a day to the affected areas. improvement is usually seen after about 6 weeks in most patients, However, 8 to 12 weeks of treatment may be required before maximum benefit is seen
Store below 30oC ٫ Protect from freezing and direct sun light .